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Editor-in-chief: Johanna Salomaa-Valkamo

Editor: Päivi Jokiniemi

Article related to: REACH

REACH compliance – an Agency priority for 2019

Many of the registration dossiers received by ECHA do not include all of the required information. This lack of information could mean that potential risks posed by the substances are not being managed properly. ECHA’s Executive Director Bjorn Hansen tells how the Agency intends to tackle the challenge of non-compliant data and to reduce the uncertainties around potential substances of concern.

In early October 2018, the German Federal Institute for Risk Assessment (BfR) published their study on REACH compliance. The study is based on information available in REACH registration dossiers for substances in volumes of 100 tonnes per year or more. The results indicated that between one and two thirds of registrations in the highest tonnage bands are in breach of REACH information requirements. This is similar to the observations gathered by ECHA during its compliance checks.

Missing information raises concerns

When REACH was first created, a certain level of non-compliance was expected. Today, the issue is the observed extent of it. “Back then, it was thought that for finding non-compliances it would be enough if ECHA would check five per cent of the registration dossiers in each tonnage band,” Mr Hansen says.

At this point, however, it has become clear that checking the compliance to this extent has not had the planned effect. “REACH was built purposely so that industry does its job and then we at ECHA check whether what they have done is sufficient. This means that industry should do its best to fulfil the requirements and, in particular, do so where possible without testing on animals,” Mr Hansen points out.

The fact that alternatives to animal testing have not been developed at the expected pace is problematic for industry. Since animal testing is only allowed as a last resort, registrants have used derogations more than was expected. The pressure towards using data waivers may lead to a situation where a substance is assumed to be less hazardous than what it really is.

“The absolutely crucial point is that where non-compliance exists, there may be effects of a chemical which go unnoticed. This is, of course, not the case for all non-compliant dossiers, but it is an underlying worry,” Mr Hansen explains.

Bjorn Hansen. Image: ECHA.

"The absolutely crucial point is that where non-compliance exists, there may be effects of a chemical which go unnoticed. This is, of course, not the case for all non-compliant dossiers, but it is an underlying worry."

Making compliance check an Agency priority

Although checking the regulatory compliance of registration dossiers has been a core task of the Agency since its early days, there will be an even greater focus on compliance check this year. According to Mr Hansen, this means that the Agency will need to free up resources so that more work can be done on dossier compliance. It is important to make use of the staff experience gained during the years of working on compliance tasks to improve efficiency and implement smarter ways of working.

Since 2010, ECHA has gradually moved from compliance checks that were based on random selection of dossiers to an approach where the focus is mainly on those substances that matter the most for human health and the environment. This targeting can be done with the help of screening tools.

With ECHA looking to continue with this approach, Mr Hansen emphasises the importance of smart compliance checks and the efficient use of resources. “A compliance check of a dossier where the substance is non-hazardous but the data is non-compliant requires exactly the same amount of work as a check where the substance is hazardous and the information non-compliant. Therefore, it is more effective and serves European citizens better if we focus on those substances that we suspect to be hazardous.”

Aiming to deliver more

Both civil society and the European Commission have expressed their concern over the low dossier compliance. As deficiencies in dossiers can be addressed through compliance check decisions, Mr Hansen expects ECHA to be asked to perform more compliance checks already during 2019.

“I would think that the Commission would want to raise the number of compliance checks from the current percentage because there is more non-compliance than what we originally expected. We are already planning for this and are increasing our efforts to make sure that we can deliver on the promise of protecting European citizens. So it all fits together.”

Delivering more does not only mean an increased number of checks. “For me, what matters is that we learn to do our work better, and are more efficient and focused. For example, if the end result is not a massive increase in numbers, but instead, we get better at identifying substances with non-compliant data that we suspect to be hazardous, then that is also worthwhile. So, the same number of compliance checks could result in more decisions. For me, that would be a success. This Agency has a lot of competence and a high level of motivation and commitment," Mr Hansen says and continues, "so all the prerequisites for being able to respond to the potential request from the Commission are there.”

How can we encourage updates?

Even though ECHA checks compliance, it is industry’s responsibility to make sure that its dossiers actually are compliant.

Regardless of whether the interpretation that companies are not updating their dossiers to the necessary degree is correct, ECHA strongly encourages companies to be proactive in updating their information. “One of the ways in which we encourage companies to update is through our cooperation with industry associations. For example, we have discussed how to improve dossiers and tailor them better to the needs of authorities and of the companies themselves with Eurometaux, the petroleum industry and Cefic,” Mr Hansen explains.

The ultimate aim of this work is to help companies update their dossiers with better hazard information and with the use information received from their own supply chains. Eventually, this could lead to a situation where authorities do not need to take an action as the registrations clearly document the safe use. “We do see that companies update their dossiers when we take action. Examples of this could be when we inform them of upcoming compliance checks or restriction intentions. However, when there is no action from us, the amount of updates is limited.”

The need for an implementing act to clarify the legal requirements on dossier updates has been increasingly recognised. At the moment, the REACH Regulation states that companies must update their registrations with relevant new information 'without undue delay’. “I think defining what undue delay actually means is the main element, because legally speaking it is a difficult term to interpret,” Mr Hansen says.

He explains that it is not only about it being difficult for companies to know when they need to update their dossiers – it is also difficult for authorities to know when to enforce this.

We need to work together

The interface between ECHA and national enforcement authorities is another area where further clarification could help the cooperation. ECHA can carry out certain checks in the dossier, but only the Member State enforcement authorities are able to make sure that the information included in the dossier is actually correct.

“At ECHA, we can check whether the company has provided an address, a name of a company, a contact person and a telephone number in their registration. However, we cannot verify that they have provided the address, the name of the company, the contact person and the telephone number that they should have. The national authority can do that. And this is very important, particularly when we get into much more complicated information in the dossier,” he points out.

However, whether we are talking about the number of compliance checks done, the number of updated dossiers, the compliance of the information or the responsibilities of the different actors in the process, it is evident that everyone’s contribution is needed. “This is a regulation which holds very high expectations and a high workload. But while working on our parts, we also have to regularly take a step back, check what is going on, and reflect on whether we are doing things the right way and make changes if we are not. It is just a natural learning curve,” he concludes.

ECHA’s approach to compliance checks

ECHA checks at least five per cent of the registrations in each tonnage band for compliance. Dossier selection for compliance check can be either random or based on specific concerns.

Since 2015, ECHA has mainly targeted compliance checks on substances of potential concern and the focus has been on key information requirements which allow authorities to identify if the substance is likely to be carcinogenic, mutagenic and reprotoxic (CMR) and/or (very) persistent, bioaccumulative and toxic (PBT/vPvB).

I've been working in the chemical industry for over ten years and I learned something from the industry which is 10% of the SDSs are RELIABLE! How the companies or enterprises can be so unconcerned?? I respect what ECHA is trying to do here. However, it's not enough. I think, there is a "bad-code" in the regulation: "self-classification". This intend is too optimistic; it ignors that legal entities are in control of HUMANS who are easily corrupted (they want more MONEY and less problems). They're not MACHINES which follow the instructions literally or GOOD people who want be part of the great design of a BETTER FUTURE for mankind / the whole world. I suggest that an "independent authority" should be established to classify the chemicals / products, ECHA should give the authority and control those entities and the companies / enterprises just pay the bills...